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Nyxoah Gains Favorable CMS Reimbursement Ruling for Genio System
ZACKS· 2025-12-01 15:16
Core Insights - Nyxoah (NYXH) has received a significant boost in reimbursement rates for its Genio hypoglossal nerve stimulation (HGNS) implants following the finalization of the CY2026 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgery Center (ASC) Rule by the U.S. Centers for Medicare & Medicaid Services (CMS) [1][8] Group 1: Reimbursement Changes - The CPT Code 64568 for Genio implants has been assigned to New Technology Ambulatory Payment Classification (APC) 1580, leading to increased reimbursement rates [1][9] - The new reimbursement rate for hospital outpatient departments is approximately $45,000, reflecting a 48% increase from 2025 levels [9] - The ASC facility reimbursement rate is set at $42,373, which is a 58% increase compared to 2025 [9][10] Group 2: Market Impact - The increase in reimbursement rates is expected to enhance the adoption of Genio implants, driving procedural throughput and expansion in Medicare-heavy institutions [5][10] - The single-incision procedure of Genio is well-suited for the ASC environment, creating new opportunities for therapy expansion [10] - Despite a 40% decline in share price this year, the improved reimbursement landscape may positively influence Nyxoah's prospects in 2026 [4][5] Group 3: Product Approval and Market Position - The Genio implant is approved for treating obstructive sleep apnea (OSA) through neuromodulation, with initial CE mark received in 2019 [2] - FDA approval was granted in August for a subset of adult patients with moderate to severe OSA [3] - The recognition of hypoglossal nerve stimulation as a high-value therapy for OSA is reinforced by the significant reimbursement rate increases [10]